CellGenix® rh TNF-α
GMP and Preclinical grade
CellGenix Recombinant Human TNF-α reliably stimulates the maturation of immature dendritic cells (DCs). CellGenix rh TNF-α is produced in our dedicated animal-free facility ensuring maximum safety for optimal use in ATMP manufacturing.
Tumor necrosis factor alpha (TNF-α) is a cytokine that plays a central role in inflammation, immune system development, apoptosis, and lipid metabolism. It is mainly produced by monocytes and macrophages as a response to infection, injury, or tumor burden. TNF-α can also be produced from a range of other cell types such as T cells, natural killer cells (NK cells) and neutrophils.
CellGenix TNF-α is used in the cell and gene therapy space for the ex vivo maturation of immature DCs.
CellGenix GMP Recombinant Human TNF-α is produced following all applicable GMP guidelines and allows for the safe use in accordance with USP Chapter <1043> and Ph. Eur. General Chapter 5.2.12.
Our GMP cytokines are provided with documented evidence of purity, potency, consistency and stability. In combination with our expert regulatory and technical support this will help simplify your raw material qualification and validation efforts.
CellGenix® Recombinant Human Tumor Necrosis Factor-alpha
CellGenix® GMP rh TNF-α
CellGenix® Preclinical rh TNF-α
CellGenix® rh TNF-α
- Produced in our dedicated animal-free facility
- Compliant to USP Chapter <1043> and Ph. Eur. General Chapter 5.2.12 (GMP)
- FDA Drug Master File available (GMP)
GMP & Preclinical Grade
- Seamless transition from preclinical development to ATMP manufacturing
Highest GMP Quality Standard
- High lot-to-lot consistency – save time on revalidations
- Performance reliability – rely on consistent product performance
- Highest purity – ensure the safety of your ATMP
- Extremely low endotoxin levels – improve safety and reproducibility
- Expert regulatory & technical support – rely on experience
Read more about our GMP Quality
Safe │ GMP Compliant │ Reliable
Expressed in E. coli
Human TNF-α, accession # P01375, Val77-Leu233
Lyophilized from 200 µl of a 0.2 µm-filtered solution containing 1.5 mM potassium phosphate, 8.1 mM sodium phosphate, 2.7 mM potassium chloride and 137 mM sodium chloride, pH 7.5
Both product grades are produced under the same conditions in a GMP facility, ensuring an equal product quality and performance. We offer a more comprehensive QC testing including tighter specifications and documentation for our GMP products: Preclinical vs GMP
|Molecular weight||17.5 kDa||17.5 kDa|
|Purity||≥ 95% as determined by SDS-PAGE||≥ 97% as determined by SDS-PAGE|
|Activity||≥ 10 x 106 IU/mg, calibrated against NIBSC #88/786||20 – 80 x 106 IU/mg, calibrated against NIBSC #88/786|
Batch specific activity on CoA
|Endotoxin level||< 1000 EU/mg||≤ 50 EU/mg|
|Intended use||Intended for preclinical ex vivo use. Not intended for human in vivo application.||Intended for clinical ex vivo use. Not intended for human in vivo application.|
Recommended in sterile water to a final concentration of 250 µg/ml.
Ambient temperature. Please refer to Technote to learn more about our shipment validation procedure.
Storage & Stability
Store lyophilized cytokine at -20°C to -80°C.
Avoid repeated freeze/thaw cycles.
CellGenix GMP rh TNF-α has an activity of 20 – 80 × 106 IU/mg
The activity of GMP rh TNF-α was measured in a cell cytotoxicity assay using L929 cells. It was calibrated against NIBSC #88/786.
You can find the batch specific activity on the certificate of analysis (CoA).
We offer the following to assist you with your regulatory approval process:
- Comprehensive documentation (e.g. DMFs, Regulatory Support Files, Certificates of Origin)
- Outstanding QC support (e.g. extensive stability data)
- The possibility to audit our production site
- Detailed batch specific test results on our Certificates of Analysis
- Change notifications prior to relevant changes
Customized solutions can be provided to meet special compliance needs. Contact our Regulatory Support Team for all your regulatory requests & questions:
Phone: +49 761 88 88 9-302
In order to stay up-to-date with the international guidelines for raw materials, we are in constant interaction with regulatory authorities worldwide. In this regard, we amongst others helped defining the European guidelines which are outlined in the new general chapter Ph. Eur. monograph 5.2.12.
- A phase I clinical trial combining dendritic cell vaccination with adoptive T cell transfer in patients with stage IV melanoma
Poschke, I. et al., 2014, Cancer Immunology, Immunotherapy
- Comparison of clinical grade type 1 polarized and standard matured dendritic cells for cancer immunotherapy
Hansen, M. et al., 2013, Vaccine
- Melanoma immunotherapy using mature DCs expressing the constitutive proteasome
Danull, J. et al., 2013, The Journal of Clinical Investigation
- In-chip fabrication of free-form 3D constructs for directed cell migration analysis
Olsen, MH. et al., 2013, Lab on a Chip
- Therapeutic vaccination against autologous cancer stem cells with mRNA-transfected dendritic cells in patients with glioblastoma
Vik-Mo, EO. et al., 2013, Cancer Immunology Immunotherapy
- The natural killer cell response and tumor debulking are associated with prolonged survival in recurrent glioblastoma patients receiving dendritic cells loaded with autologous tumor lysates
Pellegatta, S. et al., 2013, Oncoimmunology
- A phase II study evaluating the safety and efficacy of an adenovirus-DLMP1-LMP2 transduced dendritic cell vaccine in patients with advanced metastatic nasopharyngeal carcinoma
Chia, WK. et al., 2012, Annals of Oncology
- Myeloid-derived suppressor cells impair the quality of dendritic cell vaccines
Poschke, I. et al., 2012, Cancer Immunology, Immunotherapy
- Is Anticancer Vaccine Possible: Experimental Application of Produced mRNA Transfected Dendritic Cells Derived from Enriched CD34+ Blood Progenitor Cells
Lazarova, P. et al., 2012, Immunodeficiency, Chapter 3
- Dendritic cell-based vaccination of patients with advanced melanoma: update of clinical outcome
Ridolfi, L. et al., 2010, Clinical and Developmental Immunology
- Immunogenicity of dendritic cells pulsed with CEA peptide or transfected with CEA mRNA for vaccination of colorectal cancer patients
Lesterhuis, WJ. et al., 2010, Anticancer Research
- Tumor endothelial marker 8 expression levels in dendritic cell-based cancer vaccines are related to clinical outcome
Venanzi, FM. et al., 2010, Cancer, Immunology, Immunotherapy
- Vaccination with autologous dendritic cells pulsed with multiple tumor antigens for treatment of patients with malignant melanoma: results from a phase I/II trial
Trepiakas, R. et al., 2010, Cytotherapy